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Re: Antti post# 206742

Wednesday, 08/21/2019 4:43:50 PM

Wednesday, August 21, 2019 4:43:50 PM

Post# of 460314
So you're saying that if the primary outcome measures are met for the entire study population, then the data can be used.

But if the primary endpoints are met for the marker positive subgroup (about 80% of them), but are not met for the marker negative subgroup (a built in negative control group), then the FDA will just ignore the data showing efficacy in an easily identifiable subgroup and just let 80% of ALZ patients continue to go untreated. Doubt it.

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